mptoms when restarting the same drug or a different DPP-4 inhibitor. Consider discontinuing drug if appropriate
.Bullous Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If suspected, discontinue QTERN
.Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with QTERN
Adverse Reactions
Most common adverse reactions reported in ≥5% of patients treated with 10 mg dapagliflozin and 5 mg saxagliptin were upper respiratory tract infection (13.6%), urinary tract infection (5.7%), and dyslipidemia (5.1%).
Drug Interactions
Strong CYP3A4/5 inhibitors (eg, ketoconazole): Coadministration with QTERN significantly increases saxagliptin concentrations. Do not coadminister QTERN.
Use in Specific Populations
.Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters
.Lactation: QTERN is not recommended when breastfeeding
Please click here for US Full Prescribing Information and Medication Guide for QTERN.
INDICATION AND LIMITATIONS OF USE for FARXIGA® (dapagliflozin)
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
IMPORTANT SAFETY INFORMATION for FARXIGA® (dapagliflozin)
Contraindications
.History of a serious hypersensitivity reaction to FARXIGA
.Severe renal impairment (eGFR <30 mL/min/1.73 m2), end stage renal disease, or patients on dialysis
Warnings and Precautions
.Hypotension: FARXIGA causes intravascular volume contraction, and symptomatic hypotension can occur. Assess and correct volume status before initiating FARXIGA in.patients with impaired renal function, elderly patients, or patients on loop diuretics. Monitor for hypotension
.Ketoacidosis has been reported in patients with type 1 and type 2 diabetes receiving FARXIGA. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue FARXIGA, eva luate and treat promptly. Before initiating FARXIGA, consider risk factors for ketoacidosis. Patients on FARXIGA may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis
.Acute Kidney Injury and Impairment in Renal Function: FARXIGA causes intravascular volume contraction and renal impairment, with reports of acute kidney injury requiring hospitalization and dialysis. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. FARXIGA increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Before initiating FARXIGA, eva luate renal function and monitor periodically. FARXIGA is not recommended in patients with an eGFR persistently between 30 and <60 mL/min/1.73 m2
.Urosepsis and Pyelonephritis: SGLT2 inhibitors increase the risk for urinary tract infections [UTIs] and serious UTIs have been reported with FARXIGA. eva luate for si
